User:CorporateM/CoolSculpting

CoolSculpting is a noninvasive body sculpting procedure. It uses controlled cooling techniques, called Cryolipolysis, to freeze fat cells at a temperature tolerated by the skin, causing fat cells to die and re-digest into the body. Patients are treated by having a fatty area sucked into a CoolSculpting device that cools the area. The procedure is cleared by the Food and Drug Administration, Health Canada and the European Union. Side effects include temporary bruising, pain, skin stiffness and a loss of sensitivity.

The CoolSculpting procedure is considered a safe, effective treatment that results in about 25 percent reduction in the patient's fat layer and has high rates of patient satisfaction. It is most effective for reducing fat in the abdomen or sides. CoolSculpting is intended for body contouring to remove specific fat bulges and not for general weight loss.

CoolSculpting systems are sold by ZELTIQ Aesthetics Inc. It earns revenue by selling systems and consumable and charging a fee for each treatment. The company raised $50 million in funding by 2005 and went public in 2011, raising $91 million.

Treatment
CoolSculpting is a noninvasive body sculpting procedure. It is based on Cryolipolysis, the process of cooling fat cells, causing apoptosis (shrinkage and eventual death). Afterward the fat cells are consumed by macrophages in the body. It cools the fat through the patient's skin. Blood and nerves freeze at zero degrees centigrade, whereas fat freezes at 4 degrees. The product is marketed as an alternative to liposuction, that has no anaesthesia, incisions or recovery periods.

The CoolSculpting treatment process involves a fatty area of the body being sucked into a suction cup-type device and cooled. A gel patch is placed on the skin before being sucked into the machine. Different shapes of suction cup and different programming in the machine are used for different areas of the body. The patient experiences mild pain or discomfort for a few minutes until the area becomes numb.

Typically an individual treatment lasts one hour for each part of the body being treated and involves two treatments, eight weeks apart. The number and duration of treatments vary depending on the treatment area and target weight-loss. Afterwards patients can resume normal activities, but may experience sores, itching, bruising, pain or numbness in the treated area for two weeks. After the fat cells die, they are absorbed into the body and flushed out over the following several weeks or months. Following treatment, visible results can usually be seen within 3 weeks, with the most dramatic results occurring between 1-3 months; it can take up to 6 months to see full results.

Efficacy
In 2008, doctors from the Wellman Center for Photomedicine experimented with what they called "selective cryolysis" on pigs using prototype CoolSculpting systems. They found that a 30-60 minute cold exposure caused a 30-50 percent loss in a pig's fat layer over 90 days, without causing damage to skin tissue or nerves or causing changes in lipids. Prior research had indicated that fat cells were more susceptible to cold than the surrounding tissue. For example, children that excessively suck on popsicles lose fat in their cheeks, a phenomenon known as "‘popsicle panniculitis’’.

Human trials in 2009 using ultrasound measurements found that subjects lost fat cells over 2-3 months following cold exposure. A trial with eight patients resulted in a median reduction in the fat layer of 20.4 percent two months after treatment, whereas a larger trial with 32 subjects found a 22.4 percent reduction after four months. In a 2009 study of ten subjects, patients experienced an average 25.5 percent reduction in the fat layer six months after treatment. A 2013 evaluation of 518 patients found an average 23 percent reduction in the fat layer.

The CoolSculpting procedure is ideal for localized discrete fat bulges, such as love handles and the abdomen. The 518-patient study reported that flanks (sides) and abdomen (stomach) treatments were effective 85.5 percent of the time, while thighs and buttocks treatments had marginal results. At the time, these were the only treatment areas approved by the FDA and any other area was considered off-label use. Though later a new CoolSculpting device was introduced that was cleared by the FDA for thighs.

According to CBS, subsequent treatments may improve results, but the first treatment is the most effective.

Adverse effects
In 2013, a study of 518 subjects found that patients experienced redness in the treated area 100 percent of the time, as well as temporary clay-like (52%) or stiff (48%) skin. Ninety-six percent of subjects reported some discomfort. In rare cases treatment caused fainting (2.1%), severe pain (4%) or bruising (9.8%). Most side-effects subsided in about 5 minutes. No long-term side-effects were identified in any patients and adverse effects subsided without medical intervention. A 2009 study found that one-third of ten subjects evaluated experienced a temporary loss in feeling in the treated area. Two clinical trials in 2009 and 2012 found that the dying fat cells did not cause abnormal liver function or lipid levels in human or animal subjects.

According to ZELTIQ, the treatment is for "sculpting" stubborn areas of the body, as opposed to significant "weight loss" and is not intended for obese patients. According to The Wall Street Journal a lot about how fat cells function is still unknown. Excessive destruction of fat cells could cause over-production of leptin, which tells the body to eat more, or prompt the body to create new fat cells near the heart or other organs, causing health problems.

According to an article in Clinical, Cosmetic and Investigational Dermatology, out of non-invasive fat reduction techniques like radio, laser, and ultra-sound, cryolipolysis has been around the longest and is best studied through clinical trials. Liposuction is the most common and effective means of removing fat from the body, but is an invasive procedure with significant risks and side effects, such as scarring, pain, infection, and long-term recovery periods.

Reception
A 2013 study of 518 CoolSculpting treatments found that 73 percent of patients were "satisfied" or "extremely satisfied" and 83 percent would recommend the procedure to a friend. A study of 528 patients published in Aesthetic Surgery Journal said only about 1 percent of patients were dis-satisfied and all but one dis-satisfied client was satisfied after an additional CoolSculpting treatment was provided for free. A 2011 study published in Laser Medical and Surgery Journal found that 80 percent of patients reported being satisfied six months after treatment. The authors of the 528-patient study found that the majority of CoolSculpting patients had not previously had any cosmetic treatments and came in specifically for the CoolSculpting procedure. Forty percent of CoolSculpting patients returned to the same business for other procedures afterwards.